Siklos
- Product NDC
- 71770-120
- 11-digit product format
- 717700120
- Labeler code
- 71770
- Product ID
- 71770-120_47d0b61d-ad65-d2e0-e063-6294a90afe50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyurea
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medunik
- Application
- NDA208843
- Marketing category
- NDA
- Marketing start
- 2018-04-15
- Substance
- HYDROXYUREA
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Siklos
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 283475, 1999308, 1999314, 1999316 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71770-120-30 | Siklos | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 71770-120-30 | Siklos | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71770-120 | SIKLOS (HYDROXYUREA) TABLET, FILM COATED [MEDUNIK] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250207_76957c0d-0f98-4376-bb06-eee651adc09d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71770-120-30 | 71770012030 | 1 BOTTLE in 1 CARTON (71770-120-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-04-15 | 0000-00-00 | No | No | Current |